AESCULAP ELAN 4 FIXED DURAGUARD STANDARD recalled over labeling errors

Recall date

August 18, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Aesculap AG recalls AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.

Recall number

Z-0026-2026

FDA classification

Class II

Brand / firm

Aesculap AG

Sold / distributed

US distribution to Missouri. OUS International distribution to Norway, Portugal, France, Great Britian, Czech Republic, Germany, Turkey, Brazil, Japan, Chile, China, Hong Kong, Indonesia, India, Iran, Mexico, Malaysia, Philippines, Saudi Arabia, Thailand.

Why it was recalled

Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.